# PJA: Coronary Vascular Physiologic Simulation Software

- Device class: 2; regulation: 21 CFR 870.1415; FDA's rule: 510(k) required
- FDA decisions: 10
- 510(k) review time 2021–2025: median 124 days (middle half 100–177)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2014: 1
- 2016: 2
- 2018: 1
- 2019: 1
- 2021: 1
- 2022: 2
- 2025: 1
- 2026: 1

## Most-cited predicates
- K161772: FFRct (2016), cited by 3
- DEN130045: Heartflow Ffrct (2014), cited by 2
- K213857: HeartFlow Analysis (2022), cited by 1
- K182035: FFRct (2018), cited by 1
- K190925: HeartFlow FFRct Analysis (2019), cited by 1
- K152733: FFRct (2016), cited by 1
- K203329: HeartFlow Analysis (2021), cited by 1

Source page: https://510kreport.com/product-code/PJA
Data by year (CSV): https://510kreport.com/product-code/PJA.csv